U.S. Human Fibrinogen Concentrates Market Evolving Healthcare Demand

Revenue, 2025

USD 172.95 Million

Forecast, 2035

USD 714.42 Million

CAGR, 2026-2035

15.24%

Report Coverage

United States

U.S. Human Fibrinogen Concentrates Market Size, Key Players with Shares and Growth

The U.S. human fibrinogen concentrates market size was estimated at USD 172.95 million in 2025 and is predicted to increase from USD 199.31 million in 2026 to approximately USD 714.42 million by 2035, expanding at a CAGR of 15.24% from 2026 to 2035.

The U.S. human fibrinogen concentrates market is significantly driven by a high prevalence of bleeding disorders, a large number of surgical procedures, and major product approvals. The fibrinogen concentrates are highly useful in trauma care and high-risk surgeries.

Key Takeaways

• The U.S. human fibrinogen concentrates market will likely exceed USD 199.31 million by 2026.
• Valuation is projected to hit USD 714.42 million by 2035.
• Estimated to grow at a CAGR of 15.24% starting from 2026 to 2035.
• By product type, the lyophilized fibrinogen concentrates segment dominated the U.S. human fibrinogen concentrates market in 2025, with a revenue share of 50%.
• By product type, the liquid fibrinogen concentrates segment in the market is expected to grow significantly during the forecast period.
• By deployment type, the on-premise segment dominated the market in 2025, with a revenue share of 60%.
• By deployment type, the cloud-based/centralized supply systems segment is expected to grow at the fastest CAGR in the market during the forecast period.
• By application, the surgical bleeding management segment dominated the market in 2025, with a revenue share of 40%.
• By application, the congenital fibrinogen deficiency segment is expected to grow at the fastest CAGR in the market during the forecast period.
• By end-user, the hospitals & surgical centers segment dominated the U.S. human fibrinogen concentrates market in 2025, with a revenue share of 60%.
• By end-user, the pharmaceutical & biotech companies segment is expected to grow at the fastest CAGR in the market during the forecast period.

Quick Facts Table

What is the U.S. Human Fibrinogen Concentrates Market?

The U.S. human fibrinogen concentrates market refers to the commercial and clinical segment focused on the production, distribution, and application of purified human fibrinogen products used to treat patients with congenital or acquired fibrinogen deficiencies. These concentrates play a crucial role in managing bleeding disorders, particularly in surgical, trauma, and haematological settings.

Human fibrinogen concentrates offer rapid hemostasis, reduce the risk of transfusion-related complications, and are increasingly preferred over traditional plasma-derived products due to standardized dosing, safety, and ease of administration. The market encompasses all formulations, including lyophilized powders and ready-to-use solutions, and involves a diverse set of stakeholders, including hospitals, specialty treatment centers, and pharmaceutical distributors.

What are the Benefits of AI in the U.S. Human Fibrinogen Concentrates Market?

AI contributes to supply chain management, enhances manufacturing efficiency, and assists in post-market surveillance. AI plays a vital role in expanding the U.S. human fibrinogen concentrates market by supporting manufacturing, quality control, predictive maintenance, and inventory management.

Trends & Future Outlook of the U.S. Human Fibrinogen Concentrates Market

• Recombinant Fibrinogen R&D: The industry is focusing on the research and development of recombinant fibrinogen products, which serve as a good alternative to plasma-derived products. The R&D efforts on these products aim to resolve supply chain issues and avoid the risk of pathogen transmission. These major driving forces expand the U.S. human fibrinogen concentrates market.
• Increased Healthcare Awareness and Diagnosis: There is a rising number of diagnosed bleeding disorders, and many awareness campaigns by healthcare organizations. The specialty clinics are highly adopting fibrinogen products as effective and safe alternative solutions to traditional sources. The various companies are dedicated to product innovation, which focuses on developing and launching novel formulations.

Major Investments and Product Launch in the U.S. Human Fibrinogen Concentrates Market

• In December 2025, Grifols Egypt for Plasma Derivatives planned to contribute c. 55 million euros to Egypt’s GDP in 2025 alone and projected that it would serve more than 272 million euros yearly to the country’s GDP by 2030. It has also been reported that the company has achieved clinical self-sufficiency in albumin, immunoglobulins, and coagulation factors for bleeding disorders.
• In June 2025, Grifols, situated in Barcelona, announced that its fibrinogen concentrate therapy will be ready for a commercial launch in Europe, with the expected approval from the U.S. by early 2026.

Segmental Insights

Product Type Insights

How does the Lyophilized Fibrinogen Concentrates Segment Dominate the U.S. Human Fibrinogen Concentrates Market in 2025?

The lyophilized fibrinogen concentrates segment dominated the market in 2025, with a revenue share of 50%, owing to their major advantages in clinical practice, such as standardized and precise dosing, and rapid availability and administration. There are reduced complications, improved safety, and efficacy in bleeding control. They reduce the risk of allergic reactions, volume overload, and transfusion-related acute lung injury.

Liquid Fibrinogen Concentrates

The liquid fibrinogen concentrates segment is expected to grow at the fastest CAGR in the U.S. human fibrinogen concentrates market during the forecast period due to their critical functions in restoring homeostasis, standardized dosing, reduced volume, and ease of use. They reduce the risk of transmitting infectious diseases and enhance safety. They allow for accurate and consistent dosing and treat or prevent excessive bleeding.

Deployment Type Insights

What made On-Premise the Dominant Segment in the U.S. Human Fibrinogen Concentrates Market in 2025?

The on-premise segment dominated the market in 2025, with a revenue share of 60%, owing to improved performance, reliability, and enhanced security and compliance associated with on-premise channels. These systems are highly accessible and functional during internet outages. They are important for organizations requiring 24/7 access to their data and applications, even during third-party service disruptions.

Cloud-Based/Centralized Supply Systems

The cloud-based/centralized supply systems segment is estimated to grow at the fastest rate in the U.S. human fibrinogen concentrates market during the predicted timeframe due to improved collaboration and communication, and increased agility and scalability. These systems ensure transparency, cost-efficiency, and advanced analytics. They enable automation of processes and improved risk management and resilience.

Application Insights

How did the Surgical Bleeding Management Segment Dominate the U.S. Human Fibrinogen Concentrates Market in 2025?

The surgical bleeding management segment dominated the market in 2025, with a revenue share of 40%, owing to the major role of human fibrinogen concentrates in surgical settings for rapid and targeted therapy and reduced transfusion needs. The human fibrinogen concentrates serve as a critical alternative to traditional blood products in certain high-risk surgeries. They effectively manage bleeding and avoid the risk of transfusion-related acute lung injury or volume overload.

Congenital Fibrinogen Deficiency

The congenital fibrinogen deficiency segment is anticipated to grow at a notable rate in the U.S. human fibrinogen concentrates market during the upcoming period due to the vital role of fibrinogen as an important protein for blood clotting. This protein allows the formation of stable fibrin clots to stop bleeding and promote healing. It is effective for managing joint bleeds, nose bleeds, and gastrointestinal bleeds.

End-User Insights

Why did the Hospitals & Surgical Centers Segment dominate the U.S. Human Fibrinogen Concentrates Market in 2025?

The hospitals & surgical centers segment dominated the market in 2025, with a revenue share of 60%, owing to the clinical applications of human fibrinogen concentrates in treating massive trauma, cardiac surgery, postpartum hemorrhage, and congenital fibrinogen deficiency. Fibrinogen concentrates are studied across spinal, orthopedic, and liver transplant surgeries to manage bleeding and reduce dependency on traditional blood products. They are also used in treating rare inherited disorders like hypofibrinogenemia and afibrinogenemia.

Pharmaceutical & Biotech Companies

The pharmaceutical & biotech companies segment is predicted to grow at a rapid rate in the U.S. human fibrinogen concentrates market during the studied period due to the increased pharmaceutical industry focus on product formulation, quality, and safety. The biotechnology companies prioritize robust R&D, drug discovery, clinical trials, and strategic collaborations. The major pharmaceutical and biotechnology companies in the market are LFB Group, Grifols S.A., Ethicon, CSL Behring, etc.

Country-Level Insights

U.S. Human Fibrinogen Concentrates Market Analysis

In August 2024, the U.S. Food and Drug Administration (FDA) approved the fibrinogen (human) lyophilized powder for reconstitution, named fibryga, to replace fibrinogen in bleeding patients with acquired fibrinogen deficiency. Moreover, the leading companies like Octapharma, U.S., are setting new standards in patient bleeding management. The U.S. government is dedicated to enabling the use of these products in federal healthcare settings and the regulatory approval process through the FDA.

• In June 2025, Grifols reported positive results of a phase 3 clinical trial for fibrinogen that were published in The Lancet’s eClinicalMedicine. The University of Colorado Anschutz Medical Campus announced a $29 million grant supported by Octapharma for research on fibrinogen in trauma care.

Value Chain Analysis

R&D

• The major stages in the R&D process, driving the U.S. human fibrinogen concentrates market, are clinical trials and research, regulatory submissions and approvals, and manufacturing and safety enhancements.
• Key Players: Octapharma AG, CSL Behring, Grifols, S.A., LFB Group.

Distribution to Hospitals, Pharmacies

• The various distribution channels are expanding due to the increased demand for fibrinogen concentrates, the shift from traditional products, and the regulatory framework.
• Key Players: CSL Behring, Grifols, S.A., LFB Group, Baxter International Inc.

Patient Support and Services

• The patient support programs aim to help patients manage their health conditions and access treatments.
• Key Players: CSL Behring, Octapharma AG.

Top Vendors in the U.S. Human Fibrinogen Concentrates Market

SWOT Analysis

Strengths

• The prominent growth drivers of the U.S. human fibrinogen concentrates market are pathogen safety, standardized dosage, purity, rapid availability, etc.
• The fibrinogen concentrates provide specific and targeted therapy and have a long shelf life.
• Some of them hold improved clot quality than normal plasma, and enhance the clot's resistance to fibrinolysis.

Weaknesses

• Sometimes, a risk of thromboembolic events and infectious agent transmission arises.
• The plasma-derived products have the ability to cause allergic or hypersensitivity reactions.
• Fibrinogen concentrates are more expensive than traditional blood products like fresh frozen plasma and cryoprecipitate.

Opportunities

• There are expanding clinical applications driving the U.S. human fibrinogen concentrates market, which include surgical procedures, trauma care, postpartum hemorrhage, and wound healing.
• The technological advancements and product innovation revolve around improved formulations, recombinant fibrinogen, and point-of-care testing.
• The emerging markets across various regions, strategic partnerships, and increased awareness and diagnosis expand the market.

Threats

• The potential threats in the market are associated with thromboembolic complications and allergic and anaphylactic reactions.
•  Sometimes, there is a risk of infectious agent transmission and other potential adverse events.
• The adverse events are related to neurological complications, renal failure, vomiting, nausea, chills, fever, and headache.

Recent Developments in the U.S. Human Fibrinogen Concentrates Market

• In November 2025, CSL Behring planned the investment of approximately $1.5 billion in the U.S. to advance the manufacturing of plasma-derived therapies.
• In September 2025, Kedrion Biopharma received the U.S. FDA approval for QIVIGY, which is a new 10% Immunoglobulin for intravenous use, and planned to raise investments in the U.S. to advance its global operations.

Segments Covered in the Report

By Product Type

• Lyophilized Fibrinogen Concentrates
• Liquid Fibrinogen Concentrates
• Others

By Deployment Type

• On-Premise (Hospital Pharmacies/Clinics)
• Cloud-Based/Centralized Supply Systems
• Hybrid

By Application

• Surgical Bleeding Management
• Congenital Fibrinogen Deficiency
• Trauma/Emergency Bleeding
• Liver Disease/Coagulopathy
• Other Applications

By End-User

• Hospitals & Surgical Centers
• Hemophilia/Specialty Clinics
• Pharmaceutical & Biotech Companies
• Academic & Research Institutes
• Other End-Users

By Region

• North America
  • U.S.
  • Canada 
  • Mexico 
  • Rest of North America
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Europe 
  • Western Europe 
    • Germany 
    • Italy
    • France
    • Netherlands
    • Spain
    • Portugal 
    • Belgium
    • Ireland
    • UK 
    • Iceland 
    • Switzerland
    • Poland
    • Rest of Western Europe
  • Eastern Europe 
    • Austria
    • Russia & Belarus 
    • Türkiye
    • Albania 
    • Rest of Eastern Europe 
• Asia Pacific
  • China 
  • Taiwan
  • India 
  • Japan 
  • Australia and New Zealand
  • ASEAN Countries (Singapore, Malaysia)
  • South Korea 
  • Rest of APAC 
• MEA 
  • GCC Countries
    • Saudi Arabia 
    • United Arab Emirates (UAE)
    • Qatar 
    • Kuwait 
    • Oman 
    • Bahrain 
  • South Africa
  • Egypt 
  • Rest of MEA